Status:

ENROLLING_BY_INVITATION

Breast Cancer PET/CT Imaging With 68Ga-pAKTi

Lead Sponsor:

Fudan University

Conditions:

Breast Cancers

PIK3CA Mutation-Related Tumors

Eligibility:

FEMALE

18+ years

Brief Summary

Abnormal activation of the PI3K-AKT signaling pathway in breast cancer patients is closely associated with tumor progression. Phosphorylated AKT (p-AKT) serves as a key indicator of pathway activation...

Eligibility Criteria

Inclusion

  • Voluntarily signs the informed consent form.
  • Age ≥ 18 years.
  • Pathologically confirmed or highly suspected breast cancer based on conventional imaging.
  • Estimated life expectancy \> 3 months as determined by the physician.
  • Agrees to practice strict contraception for at least 28 days following the PET/CT examination.
  • Willing and able to comply with the study protocol.
  • Has not undergone surgical resection of the lesion.
  • Has participated in molecular testing at the Precision Oncology Center of Fudan University Shanghai Cancer Center, and harbors a PIK3CA mutation, PTEN mutation, or upregulation of the PI3K-AKT-mTOR pathway.

Exclusion

  • Pregnant or breastfeeding women.
  • Unable to lie still on the PET/CT scanner bed during the examination or intolerant to PET imaging.
  • Participation in another interventional clinical trial within 1 month prior to screening.
  • Patients who are lost to follow-up.
  • Any other condition that, in the opinion of the investigator, may interfere with the study or make the subject unsuitable for participation.

Key Trial Info

Start Date :

April 21 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06943313

Start Date

April 21 2025

End Date

December 31 2026

Last Update

April 24 2025

Active Locations (1)

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1

Fudan University Shanghai Cancer Center

Shanghai, China